BioStratum Incorporated, a development-stage biopharmaceutical company
focused on novel therapies for diabetes and diabetic complications, today
announced that new human safety and efficacy data on its lead drug candidate,
Pyridorin(TM), was the focus of two presentations made at the American
Diabetes Association's 64th Scientific Sessions. The conference is being held
June 4-8, 2004, in Orlando, Florida.

Pyridorin, a small molecule that uniquely inhibits the formation of
harmful advanced glycation end-products (AGEs), has been granted Fast Track
status by the FDA and has recently completed Phase II clinical trials for the
treatment of diabetic kidney disease. AGEs are widely held to be a cause of
diabetic complications such as kidney disease (nephropathy), blindness
(retinopathy), and nerve damage (neuropathy).

Diabetic nephropathy occurs in approximately 30-40% of patients with type
1 and type 2 diabetes and is the leading cause of end stage renal disease
(ESRD) in the United States and Europe. Despite the broad use of currently
available therapeutic agents, the prevalence of diabetic nephropathy
continues to increase at an alarming rate. The annual healthcare burden of
ESRD, involving dialysis and kidney transplantation exceeds $18 billion in
the United States alone and is projected to increase dramatically due to the
ongoing epidemic of type 2 diabetes.

In one presentation, recent findings from companion studies PYR-205 and
PYR-207, two six-month, Phase IIb trials that examined the safety and
efficacy of Pyridorin were provided. The multinational, double-blind studies
involved a total of 84 patients with either type 1 or type 2 diabetes and
either mild-to-moderate (PYR-205) or moderate-to-severe (PYR-207) diabetic
nephropathy. Patients were randomized to receive either Pyridorin or placebo
in addition to standard of care therapy for diabetic nephropathy. The trial
results suggest that Pyridorin may be safe and effective in the treatment of
diabetic nephropathy:

- Pyridorin was safe and well tolerated. No significant differences in
treatment-related adverse events or study discontinuations due to
adverse events were observed.
- The rate of rise in serum creatinine, a well-accepted marker for the
progression of diabetic nephropathy, was decreased by 87% in patients
receiving Pyridorin compared to those receiving placebo (p=0.0029). In
particular, in the subset of type 2 patients who were receiving
standard therapy for diabetic nephropathy and who also had elevated
serum creatinine levels at baseline, the rate of rise in serum
creatinine was reduced by 98% in patients receiving Pyridorin compared
to those receiving placebo (p=0.0002).
- A marked benefit in patients receiving Pyridorin was also observed in
the rate of decline in creatinine clearance, a measure of kidney
function, and in the level of urinary TGF-B1 compared to patients
receiving placebo. TGF-B1 is a cytokine that has been implicated in
the development and progression of diabetic kidney disease.

In a second presentation, findings from study PYR-206, a six-month Phase
IIa trial similar in design to PYR-205 and PYR-207, were provided. The
double-blind, placebo-controlled study involved 128 patients with either type
1 or type 2 diabetes and diabetic nephropathy. Patients were randomized to
receive either Pyridorin or placebo in addition to standard of care therapy
for diabetic nephropathy. The PYR-206 study results were very similar to the
results from studies PYR-205 and PYR-207 in that a significant treatment
effect was seen in patients receiving Pyridorin on both the rate of rise in
serum creatinine and in the reduction in urinary TGF-B1 levels.

A third presentation by BioStratum and Dr. Norman E. Cameron from the
University of Aberdeen, Scotland, described new data regarding BioStratum's
second-generation AGE inhibitor, BST4997. When BST4997 was examined in an
animal model of type 1 diabetes with established diabetic neuropathy it
completely reversed the existing motor and sensory nerve dysfunction. BST4997
also completely reversed the existing deficits in response to heat and touch
stimuli. These results provide further support for AGE inhibition as a novel
therapeutic approach for treating diabetic neuropathy, which is the most
common late-stage complication of diabetes and causes significant morbidity
and mortality. Available treatments are only moderately effective in
relieving symptoms of diabetic neuropathy and are limited by adverse effects
and drug interactions. Extreme pain often accompanies diabetic neuropathy,
however, patients may also lose the ability to judge temperature or sense
even painful stimuli. Diabetic neuropathy is the primary risk factor for the
development of diabetic foot ulcers, which are responsible for 85% of
lower-extremity amputations in patients with diabetes.

&quot;With three very encouraging Phase II studies completed, BioStratum is
preparing to meet with the FDA this summer to discuss the initiation of the
Pyridorin Phase III program,&quot; said Dr. Robert J. Schotzinger, BioStratum's
President &amp; Chief Executive Officer. &quot;Additionally, the promise shown by
BioStratum's new AGE inhibitor, BST4997, at reversing established nerve
damage in an animal model of diabetic neuropathy is encouraging, and supports
our belief that BioStratum is uniquely positioned to identify new therapies
that will be effective at treating a variety of diabetic complications,&quot;
added Dr. Schotzinger.

Abstracts of the following presentations are available at the American
Diabetes Association 64th Scientific Sessions Web site,
http://www.attendeeinteractive.com/shows/ada0401/index.cfm

BioStratum is a world leader in basal lamina research and is focused on
the discovery and development of novel therapeutic agents for the treatment
of diabetes and diabetic complications. The Company's lead drug candidate,
Pyridorin(TM), has completed Phase II clinical trials for diabetic
nephropathy and has been granted Fast Track status by the FDA. Furthermore,
BioStratum has a rich pipeline of novel drug candidates and targets in the
fields of diabetes, diabetic complications and cancer. Headquartered in
Research Triangle Park, North Carolina, BioStratum's research and development
operations are further extended through multiple collaborations with leading
research centers.

A fact sheet on the company is available from BioStratum Incorporated,
(919) 433-1000, or e-mail, info@biostratum.com